FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
97057–97080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 1996
YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE
K962070 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 52d
Cleared Jul 19, 1996
ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
K962321 · HRX
Arthrocare Corp.
Orthopedic · 32d
Cleared Jul 18, 1996
HEART 400 ECG TRANSMITTER
K953762 · DXH
Aerotel, Ltd.
Cardiovascular · 342d
Cleared Jul 18, 1996
MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP
K955231 · FRN
Medex, Inc.
General Hospital · 247d
Cleared Jul 18, 1996
PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM
K960696 · KLE
Ultradent Products, Inc.
Dental · 149d
Cleared Jul 18, 1996
PACEART WRIST ELECTRODES
K960721 · DRX
Paceart, Inc.
Cardiovascular · 147d
Cleared Jul 18, 1996
MUMPS IGG TEST
K961204 · LJY
Zeus Scientific, Inc.
Microbiology · 113d
Cleared Jul 18, 1996
MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652
K961336 · LJS
Medtronic PS Medical
General Hospital · 101d
Cleared Jul 18, 1996
SUBLIMINATOR
K961457 · EJI
Healex Products, Inc.
Dental · 93d
Cleared Jul 18, 1996
LUBRICATING JELLY, LOW VISCOSITY
K961502 · KMJ
Span-America Medical Systems, Inc.
General Hospital · 90d
Cleared Jul 18, 1996
BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE
K961505 · GEI
Conmedcorp
General & Plastic Surgery · 90d
Cleared Jul 18, 1996
PERKINS HAND-HELD APPLANATION TONOMETER
K961512 · HKY
Clement Clarke, Inc.
Ophthalmic · 90d
Cleared Jul 18, 1996
A PORT DETACHED CATHETER SYSTEM CATALOG #1002
K961583 · LJT
Arrow Intl., Inc.
General Hospital · 85d
Cleared Jul 18, 1996
OLYMPUS BASKET GRASPERS (UROLOGY)
K961611 · OCZ
Olympus America, Inc.
Gastroenterology & Urology · 84d
Cleared Jul 18, 1996
SOLO CPAP SYSTEM
K961626 · BZD
Respironics, Inc.
Anesthesiology · 83d
Cleared Jul 18, 1996
NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS
K961717 · DWF
Naltiac Medical, Inc.
Cardiovascular · 77d
Cleared Jul 18, 1996
CERAMCO CROWNS AND BRIDGES
K961720 · EJH
Eric S. Small, Dds
Dental · 76d
Cleared Jul 18, 1996
17 ANGULATED ABUTMENT
K961736 · NHA
Nobelpharma USA, Inc.
Dental · 76d
Cleared Jul 18, 1996
AUTO SUTURE CHEMOSITE TUNNELER
K961856 · LJS
United States Surgical, A Division of...
General Hospital · 65d
Cleared Jul 18, 1996
CIRCLE NEPHROSTOMY CATHETER SET
K961933 · LJE
Cook Urological, Inc.
Gastroenterology & Urology · 62d
Cleared Jul 18, 1996
TUAT SPLATTER CONTROL SHIELD SCS-300
K962003 · KKX
Taut, Inc.
General Hospital · 57d
Cleared Jul 18, 1996
3M VITREBOND LIGHT CURE GLASS IONOMER/BASE
K962065 · EMA
3M Company
Dental · 51d
Cleared Jul 18, 1996
AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
K962123 · FNM
Lumex, Inc.
General Hospital · 48d
Cleared Jul 18, 1996
STERNGOLD G-HARD METAL ALLOY
K962301 · EJS
The Stern Metals Co., Inc.
Dental · 31d